Prostate Cancer Clinical Trial
— ProBioMOfficial title:
Developing a Multivariable Diagnostic Prediction Model for Prostate Biopsy Outcome Using Biomarkers and mpMRI as Prediction Variables in Biopsy naïve Men.
Verified date | March 2023 |
Source | Odense University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Current standard prostate biopsy techniques, used to definitively diagnose prostate cancer (PC), utilises an ultrasound guided biopsy approach, that offers unsatisfactory specificity and sensitivity for clinical significant PC. This often leads to harmful unnecessary biopsies. To improve the overall detection of clinical significant PC, multiparametric magnetic resonance imaging (mpMRI) has emerged as a new technique that might be useful in selecting the appropriate patient for biopsy. Nevertheless, mpMRI fail to detect cancer in some circumstances and the exact role of mpMRI is undetermined. Currently, the majority of PC is diagnosed either incidentally or by unsystematic screening with prostate specific antigen (PSA). PSA suffers from being an organ specific, but cancer unspecific serum biomarker. PSA testing may neither rule out or confirm the presence of prostate cancer. Newer biomarkers have shown promise in curbing some of this sensitivity and specificity gap, but still needs refinement. In the present study, the investigators will use mpMRI and a new set of urine and plasma biomarkers in combination, prior to performing standard biopsies in order to develop a prediction model for the biopsy outcome. If proven successful the model would offer excellent risk stratification and possibly mitigating the need for biopsies.
Status | Completed |
Enrollment | 261 |
Est. completion date | June 1, 2022 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Able to provide informed written consent. 2. PSA < 20. 3. Referred for prostate biopsy. Exclusion Criteria:: 1. Previously diagnosed with prostate cancer. 2. Active use of anticoagulant (excluding platelet inhibitors) or other contraindication for prostate biopsies. 3. Previously undergone prostate biopsies. 4. Inability to undergo mpMRI scan (pacemaker , claustrophobia, impaired renal function, allergy towards contrast agent etc) 5. Any, previous or current, therapy for benign prostate hyperplasia including surgery or medical therapy (except alpha adrenal blockers). 6. They withdraw their consent. |
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital | Odense |
Lead Sponsor | Collaborator |
---|---|
Torben Brøchner Pedersen |
Denmark,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Health Related Quality of Life | Assessed utilizing the EuroQoL EQ-5D-5L questionnaire (comprising 5 questions with a score from 1 to 5 each and a visual analogue scale from 0 to 100). | Baseline, 24 hour, 1 month and 12 months | |
Primary | Detection of clinical significant cancer. | Positive biopsies with a Gleason grade > 7. | 1 month | |
Secondary | Detection rate of any cancers | Positive biopsies, any Gleason grade. | 1 month |
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